Otc - Active Ingredient
ARNICA MONTANA FLOWER
Putrizen Numbing Cream
FDA Label NDC 84983-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou South Moon Biotechnology Co., Ltd. for the product Putrizen Numbing Cream (NDC 84983-027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the temporary relief of localized pain, itching, or discomfort from minor skin irritations.
Otc - When Using
1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.
Warnings
For external use only.
Otc - Do Not Use
Do not get into the eyes.m Do not exceed recommended dosage unless directed by a doctor. m Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Otc - Stop Use
Do not get into the eyes.m Do not exceed recommended dosage unless directed by a doctor. m Do not
put this product into the rectum by using fingers or any mechanical device or applicator.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Storage And Handling
Store at room temperature 59°F-86°F(159C-309C).Avoid direct sunlight Do not use if tamper-evident packaging has been breached or is missing!
Inactive Ingredient
EUCALYPTUS GLOBULUS LEAF、EMU OIL、AQUA、GLYCERIN、MENTHOL、MINERAL OIL、GLYCERYL MONOSTEARATE、1,2-HEXANEDIOL、CARBOMER HOMOPOLYMER TYPE A、TROLAMINE
Dosage & Administration
1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.
Indications & Usage
1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.
Package Label.Principal Display Panel
Label (Dsku 00000809)
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